- Organon & Co. (Jersey City, NJ)
- …project teams and alliance partners to develop and implement world-wide regulatory strategies for assigned biosimilar projects, with a specific focus on ... Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role...development due diligence activities. **Responsibilities** + Provide global strategic regulatory CMC overview for respective products and portfolio. +… more
- Merck (Austin, TX)
- **Job Description** This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary ... responsibility for this position is to ensure regulatory compliance for the company's portfolio of medical devices...aspects are integrated + Stay abreast of evolving global regulatory landscapes for medical device and medical device combination… more
- Merck (De Soto, KS)
- **Job Description** **JOB DESCRIPTION SUMMARY** The Associate Principal Scientist is a DVM/VMD and/or PhD whose primary function is to design, coordinate, ... clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products....studies, and occasionally Good Laboratory Practice (GLP) studies. The Associate Principal Scientist is the… more
- Merck (West Point, PA)
- …and pharmaceutical products and combination products. We are seeking an experienced Associate Principal Scientist to advance and commercialize biologics ... to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The...a member of the biologics drug product team, the Associate Principal Scientist will have… more
- Astrix Technology (North Wales, PA)
- ** Associate Principal Scientist (Epidemiology)** Clinical North Wales, PA, US Pay Rate Low: 58.67 | Pay Rate High: 71.43 + Added - 14/04/2025 Apply for Job ... and innovative animal-health products, is in search of an Associate Principal Scientist to join...selection of an appropriate endpoint measure to satisfy both regulatory and reimbursement needs + Coordinate COA/PRO related sections… more
- Merck (West Point, PA)
- …within Analytical Chemistry in Development and Supply (ACDS) is seeking applicants for an Associate Principal Scientist position available at the West Point, ... to drive late-stage pharmaceutical drug product development and commercialization. The Associate Principal Scientist responsibilities include, but not… more
- Merck (West Point, PA)
- …Bioanalytics (PDMB) in West Point, PA is seeking a highly motivated Associated Principal Scientist with wide knowledge of pharmacokinetic (PK) and toxicokinetic ... exploratory and definitive/Good Laboratory Practice (GLP)], serving as a contributing scientist / principal investigator on toxicity studies, and executing PK/TK… more
- Bristol Myers Squibb (Cambridge, MA)
- …track record of high-quality scientific publications in relevant fields For the Sr. Principal Scientist position, the starting compensation for this job is a ... oncology. + Manage relationships with key internal stakeholders including regulatory , clinical and commercial and scientific communications and external… more
- Merck (Durham, NC)
- **Job Description** The Associate Principal Scientist position will support our Bacillus Calmette Guerin (BCG) franchise. This broad role includes driving ... supply chain, site and global Quality, as well as CMC- Regulatory . This role will be based in Durham, NC,...+ Writing or review of technical documents, preferably including regulatory filings (IND, MAA, BLA, PAS, CBE) and inspections… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** The Associate Director/ Principal Scientist , Cell Culture Process Development ... development, platform process evolution, and to support cell culture-related regulatory documentation. **Key Responsibilities:** + Optimize and characterize cell… more
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